|Title:||Urinary follicle stimulating hormone|
|Abstract:||Purification of human FSH from post-menopausal urine gonadogropin using immunochromatography and reverse phase HPLC steps yelds a biologically active hormone which is free from detectable traces of LH and other urinary proteins.|
|Inventor(s):||Arpaia; Guiseppe (Rome, IT), Serani; Serenella (Rome, IT), Sirna; Antonino (Rome, IT), Villa; Stefano (Rome, IT)|
|Assignee:||Istituto di Ricerca Cesare Serono S.p.A. (Rome, IT)|
|Filing Date:||Dec 29, 1995|
|Claims:||1. A process for preparing a substantially pure biologically active follicle stimulating hormone (FSH) preparation, free from traces of luteinizing hormone detectable at 1.5 mIU/ml, based on the 2nd IRP-HMG reference standard for luteinizing hormone, and substantially free from all other urinary proteins, comprising subjecting a post-menopausal urinary concentrate to immunopurification using FSH-specific immobilized monoclonal antibodies to form an immunocomplex of FSH and the antibodies thereto, eluting to recover the FSH, and removing any residual traces of contaminants by reverse phase HPLC. |
2. The process of claim 1 wherein the post-menopausal urinary concentrate contains Human Menopausal Gonadotropin.
3. The process of claim 1 wherein elution of FSH from the immunocomplex is carried out using as eluent an aqueous solution having a pH higher than about 10 and a molarity higher than about 0.5.
4. The process of claim 3 wherein the eluent has a pH comprised within the range of 11.3 to 11.7 and a molarity of about 1.
5. The process of claim 4 wherein the eluent is 1M ammonia.